Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Not Applicable

Completed

• Conditions: Congenital Hypothyroidism
• Interventions: Drug: Levothyroxine; Device: Ultrasound

• Registration Number: NCT02374593
• Lead Sponsor: Erica Eugster

Brief Summary

This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-06-06
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-06
• Last Update Submitted: 2017-10-06
• Results First Posted: 2017-10-09
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Newborns diagnosed with congenital hypothyroidism (CH).
• Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for Children or satellite location.
• Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis.

Exclusion Criteria

• Newborns who do not have CH.
• Newborns with CH who have not had thyroid imaging performed at diagnosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted dosing	Ultrasound	Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
Targeted dosing	Levothyroxine	Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.

Primary Outcome Measures

Name	Time	Method
Dose Adjustments	6 months	Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.

Secondary Outcome Measures

Name	Time	Method
Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls	6 months	Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States